SENIOR MANAGER, CLINICAL STUDY LEAD

Company: BioSpace, Inc.
Location: Armonk
Posted on: September 21, 2024

Job Description:

Job Details

As a Senior Clinical Study Lead (SCSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study close out. These responsibilities apply to both internally sourced studies and studies outsourced to CROs, so we need a SCSL who has experience handling Third-Party Vendors. We need someone who can also give to and drive process improvement initiatives that support our rapidly growing organization. This is an exciting time to join our organization and have a direct impact on bringing life-saving treatments to the market.

As a SCSL, a typical day might include the following:

• Providing operational input into protocol development
• Leading all aspects of and giving to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
• Ensuring compliance with the clinical trial registry requirements
• Providing input into baseline budget and timeline development and running the study against planned budget, timeline and results
• Leading risk assessment and identifies risk mitigation strategies at the study level This role might be for you if:
  • You have direct management experience with demonstrated results building and developing outstanding teams
  • You have the capacity to understand and implement the strategic direction and guidance for respective clinical studies
  • You can take a proactive and self-disciplined approach to leading projects with a developed ability to meet deadlines and prioritize
  • You have a history of effectively leading and negotiating with vendors
  • You have a data-driven approach to planning, executing and problem solving
  • You operate with a high degree of cross-functional agility using exceptional influencing and social skills
  • You have the innate ability to rally disparate groups to accomplish lofty shared goals
    To be considered for this opportunity you must possess a Bachelors degree with a minimum of 8 years of relevant industry experience. Advanced degrees may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered.
    
    Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
    
    Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
    
    For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
    
    Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
    
    Salary Range (annually)
    $145,400.00 - $237,200.00

Keywords: BioSpace, Inc., Greenwich , SENIOR MANAGER, CLINICAL STUDY LEAD, Executive , Armonk, Connecticut